Good Clinical Practice eRegs & Guides - For Your Reference Book 6

Download or read book Good Clinical Practice eRegs & Guides - For Your Reference Book 6 written by eRegs & Guides and published by eregs & guides. This book was released on 2013-11-22 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: Good Clinical Practice eRegs & Guides provides a reference to key US FDA Guides and regulations via your electronic reader. An excellent way to access the reference documents on your e-reader. No need to carry paper books and you can search for key terms. In this issue you will find: ICH - Safety Guidelines S1A – S9 S1A Guideline on the Need for Carcinogenicity Studies S1B Testing for Carcinogenicity of Pharmaceuticals S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals S2(R1) Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use S3A Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies S4 Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing) S5(R2) Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S7A Safety Pharmacology Studies For Human Pharmaceuticals S7B The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) By Human Pharmaceuticals S8 Immunotoxicity Studies for Human Pharmaceuticals S9 Nonclinical Evaluation for Anticancer Pharmaceuticals